MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC PIEZO; SCALER, ULTRASONIC

Model Number USS10

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/20/2019

Event Type  Injury  

Event Description

While performing a deep cleaning the dental hygienist noticed a small burn on the patient's lip and immediately stopped the procedure.The patient left that appointment without pain but, called back a week later and said his lip had become inflamed/irritated.He was advised to take liquid benadryl, mylanta rinse, and ibuprofen as needed.Patient returned on a later date for deep cleaning and lip inflammation was resolved.

• Brand Name: PIEZO
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: stephanie wasielewski ; 3232 n rockwell st; chicago, IL 60618
• MDR Report Key: 8871127
• MDR Text Key: 153586647
• Report Number: 1416605-2019-00015
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950076092
• UDI-Public: (01)10889950076092(10)0217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: USS10
• Device Catalogue Number: USS10
• Device Lot Number: 0217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR